Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT05955469
Status:
RECRUITING
Last Update Posted:
2025-11-19
First Post:
2023-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting and a Conventional Fitting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}, {'id': 'D006312', 'term': 'Hearing Loss, Bilateral'}], 'ancestors': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003054', 'term': 'Cochlear Implants'}], 'ancestors': [{'id': 'D058117', 'term': 'Neural Prostheses'}, {'id': 'D058542', 'term': 'Implantable Neurostimulators'}, {'id': 'D004567', 'term': 'Electrodes, Implanted'}, {'id': 'D004566', 'term': 'Electrodes'}, {'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D006310', 'term': 'Hearing Aids'}, {'id': 'D012682', 'term': 'Sensory Aids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': "Double blind study: The patient and the Investigator don't know the fitting."}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': "Crossover Assignment\n\nTwo arms A and B:\n\nArm A: Bimodal patient's fitting with default fitting (FS4) --\\> 6 weeks use --\\> tests and bimodal patient's fitting with tonotopy-based fitting (TFS4) --\\> 6 weeks use --\\> tests; Arm B: Bimodal patient's fitting with TFS4 --\\> 6 weeks use --\\> tests and bimodal patient's fitting with FS4 --\\> 6 weeks use --\\> tests"}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2023-07-13', 'studyFirstSubmitQcDate': '2023-07-13', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Speech recognition in noise', 'timeFrame': 'at 6 weeks post-activation', 'description': 'The speech recognition in noise is evaluated with the French Matrix test (Framatrix) \\[S. Jansen et al. Comparison of three types of French speech-in-noise tests: a multi-center study. Int J Audiol, 51 (3) (2012), pp. 164-173\\].'}, {'measure': 'Speech recognition in noise', 'timeFrame': 'at 12 weeks post-activation', 'description': 'The speech recognition in noise is evaluated with the French Matrix test (Framatrix) \\[S. Jansen et al. Comparison of three types of French speech-in-noise tests: a multi-center study. Int J Audiol, 51 (3) (2012), pp. 164-173\\].'}], 'secondaryOutcomes': [{'measure': 'Speech recognition in quiet', 'timeFrame': 'at 6 weeks post-activation', 'description': 'Cochlear list of Lafon: list of 51 phonems (17 words). Speech recognition score on 50.'}, {'measure': 'Speech recognition in quiet', 'timeFrame': 'at 12 weeks post-activation', 'description': 'Cochlear list of Lafon: list of 51 phonems (17 words). Speech recognition score on 50.'}, {'measure': 'Auditory skills experienced by the patient', 'timeFrame': 'at 6 weeks post-activation', 'description': 'Auditory skills experienced by the patient are evaluated with the short form of the French version of the speech spatial qualities scale (SSQ) with of 15 questions describing various real-world auditory situations \\[Moulin et al. Ear \\& Hearing 2019;40;938-950\\].'}, {'measure': 'Auditory skills experienced by the patient', 'timeFrame': 'at 12 weeks post-activation', 'description': 'Auditory skills experienced by the patient are evaluated with the short form of the French version of the speech spatial qualities scale (SSQ) with of 15 questions describing various real-world auditory situations \\[Moulin et al. Ear \\& Hearing 2019;40;938-950\\].'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cochlear implant', 'Bimodal fitting', 'Anatomy-based fitting'], 'conditions': ['Sensorineural Hearing Loss, Bilateral', 'Bilateral Hearing Loss']}, 'descriptionModule': {'briefSummary': 'Main objective:\n\nFor a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy (TFS4) to a default fitting strategy (FS4) for the speech recognition in noise.\n\nSecondary objectives:\n\nComparison of TFS4 to FS4 for speech recognition in quiet. Comparison of TFS4 to FS4 for the auditory skills experienced by the subject.', 'detailedDescription': 'Introduction:\n\nCochlear implantation allows the rehabilitation of profound bilateral deafness, restoring speech perception and verbal communication when the traditional hearing aid no longer provides satisfactory hearing gain. A cochlear implant includes an electrode array and its functioning is based on the principle of cochlear tonotopy: Each electrode encodes a frequency spectrum according to its position in the cochlea (high frequencies are assigned to the basal electrodes and low frequencies to the apical electrodes). The cochlear implant thus breaks down the frequency spectrum into a number of frequency bands via bandpass filters corresponding to the number of electrodes in the implant. During the fitting these bands can be modified by the audiologist.\n\nBimodal hearing refers to the use of a CI in one ear with a HA on the contralateral side. This association allows for adults and children a better perception of speech in quiet and in noise, a better perception of music, hearing comfort, better sound quality, better localization of sound and, consequently, a better quality of life compared to unilateral CI alone. However, there is great variability in the integration process; while some bimodal users show substantial benefits, others receive little or no benefit.\n\nThis variability could be due to the mismatch of frequencies (tonotopic shift) between the CI and the contralateral HA.\n\nRecently MED-EL has developed an "anatomy-based fitting" (ABF) strategy based on the tonotopy that allows, from a postoperative scanner, to calculate the theoretical characteristic frequency of neurons stimulated by each electrode contact and to transmit this information to the fitting software of the CI.\n\nThis strategy (TFS4) could therefore allow a better integration of information in bimodal hearing and in particular improve the speech recognition in noise compared to a default strategy (FS4).\n\nMain objective:\n\nFor a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy (TFS4) to a default fitting strategy (FS4) for the speech recognition in noise.\n\nSecondary objectives:\n\nComparison of TFS4 to FS4 for speech recognition in quiet. Comparison of TFS4 to FS4 for the auditory skills experienced by the subject.\n\nPlan of the study:\n\nIt is a prospective open monocentric randomized crossover study: Measures will be done on the patient at 6 weeks and 12 weeks post-activation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient (\\>= 18 years old) speaking French\n* Patient who fulfils the criteria for cochlear implantation\n\nExclusion Criteria:\n\n* retro-cochlear pathology: auditory neuropathy, vestibular schwannoma\n* patient with residual hearing \\< 70 dB hearing level (HL) at 500 Hz and 1000 Hz on the contralateral ear'}, 'identificationModule': {'nctId': 'NCT05955469', 'briefTitle': 'Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting and a Conventional Fitting', 'organization': {'class': 'INDUSTRY', 'fullName': 'MED-EL Elektromedizinische Geräte GesmbH'}, 'officialTitle': 'Comparison of Speech Understanding Between a Tonotopy-based Bimodal Fitting and a Default Bimodal Fitting in Newly Cochlear-implanted Patients: a Double-blind Randomized Crossover Study.', 'orgStudyIdInfo': {'id': 'MEDEL_COTONBIM_StEtienne_study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'FS4 then TFS4', 'description': 'Cochlear Implant with FS4 first during 6 weeks then with TFS4 during 6 weeks', 'interventionNames': ['Device: FS4 then TFS4 (cochlear implant)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TFS4 then FS4', 'description': 'Cochlear Implant with TFS4 first during 6 weeks then with FS4 during 6 weeks', 'interventionNames': ['Device: TFS4 then FS4 (cochlear implant)']}], 'interventions': [{'name': 'FS4 then TFS4 (cochlear implant)', 'type': 'DEVICE', 'description': 'Cochlear implant with default fitting then with tonotopy-based fitting', 'armGroupLabels': ['FS4 then TFS4']}, {'name': 'TFS4 then FS4 (cochlear implant)', 'type': 'DEVICE', 'description': 'Cochlear implant with tonotopy-based fitting then with default fitting', 'armGroupLabels': ['TFS4 then FS4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42055', 'city': 'Saint-Etienne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alexandre Karkas, Pr', 'role': 'CONTACT', 'email': 'alexandre.karkas@chu-st-etienne.fr'}], 'facility': 'CHU Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'centralContacts': [{'name': 'Vincent Péan, PhD', 'role': 'CONTACT', 'email': 'vincent.pean@medel.com', 'phone': '0603592974', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Alexandre Karkas, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Saint Etienne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MED-EL Elektromedizinische Geräte GesmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}